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A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Dec 31, 2025 to Dec 31, 2026v8 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 600 to confirmed 660
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    • Study sites revised (44)
  2. Study sites: 20 to 44
    • Eligibility criteria shortened, about 520 words
    • Study description expanded, about 2 words
    v7
  3. Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Study sites: 1 to 20
    • Study completion date: Jun 30, 2025 to Dec 31, 2026
    v6
  4. Primary endpoints: 3 to 2
    • Eligibility criteria shortened, about 16 words
    • Study description shortened, about 35 words
    v5
  5. Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Study title expanded, about 4 wordsv3
  2. Study title shortened, about 7 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The objective is to evaluate the safety and efficacy of low dose and high dose CBT-001 eye drop dosed twice daily for 24 months compared to vehicle in reducing conjunctival hyperemia and preventing pterygium progression in eyes with pterygia.
Trial Details
NCT Number NCT05456425
Lead Sponsor Cloudbreak Therapeutics, LLC
Conditions
(from sponsor)		 Pterygium
Related terms Pterygium
Enrollment 660 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov